5D Health Protection Group Ltd

Biomaterials and Medical Device Testing

Biomaterials are referred to as any substance, material or technology that is engineered to be able to interact biologically for medical usage. Biomaterials can be natural or synthetic. They are used therapeutically to treat, repair or replace a function in the human or animal body. There is an increasing use of biomaterials in areas that include healthcare, regenerative medicine, dentistry, tissue scaffolds, wound care, cosmetics and implantable devices.

At 5D we are involved in evaluating and testing biomaterials for different materials that are used in medical devices including skin and wound care, dentistry, orthopaedics, personal care including cosmetics and veterinary medicine.

5D Biomaterial Testing Services

Safe and effective biomaterial products are of paramount importance. To achieve this, high quality and robust laboratory testing is crucial. At 5D we offer a large number of different biomaterial testing services. This could be related to biomaterials that release active agents including antimicrobials and antibiofilm technologies or investigating the mechanical and physical properties of biomaterials. At 5D we have a wide range of capabilities in order to understand the biosafety and biocompatibility of biomaterials. These include physical, chemical and microbiological analysis capabilities. We also support many companies investigating the cytotoxicity of their products at the early innovation stage, during development of products or after commercialisation. We offer experience with materials that may include liquids, gels, metals, composites, woven and non-woven synthetic materials, chitosan, alginates, carboxymethylcellulose, peptides and collagens.

5D Range of Testing

This testing can range from microbiology and antibiofilm testing to physical and chemical analysis of medical devices such as those used in woundcare. Testing is carried out to various standard and customised methods including, but not limited to: AATCC 100 Antibacterial finishes on textile materials; AATCC 147 Antibacterial activity assessment of textile materials: parallel streak method; ASTM E2149 Antimicrobial activity of immobilised antimicrobial agents under dynamic contact conditions; ISO 20743 Determination of antibacterial activity of textile products. Testing can be carried out using standard services strains or they can be substituted with organisms relevant to the product claims. These may include antibiotic resistant strains such as MRSA and VRE, fungal spores or Clostridium difficile. Furthermore, we do testing for companies utilising different microscopic techniques including SEM with EDX for surface analysis of surfaces. We also have access to other facilities that include atomic force microscopy that we use to measure surface roughness of surfaces and the adhesion of microorganisms to surfaces.

Analysis of Active and Leachable Agents

The impregnation of actives and antimicrobials into biomaterials is a growing industry particularly in the area of infection prevention and control. At 5D we have numerous models, techniques and methods that we use to evaluate the release profile and detection of active agents that leach or are released from biomaterials.

The 5D team are actively involved in both identifying and quantifying extractable and leachable agents from biomaterials. Further to this we offer different cytotoxicity and biocompatibility assays, tests and models to determine the risks associated with leachable from biomaterials and the effects they have on cells and healing.

Please review our scientific services pages to find the specific methods, models and assays that we use to evaluate the efficacy and performance of biomaterials. If you have any specific and bespoke requirements please contact us.

Other Medical Device Testing and Assays

5D have a very active role in the evaluation of medical devices particularly wound care products and materials. For information regarding what testing we have in you specific field please see the scientific testing pages. Dental biomaterials for example can be categorised into metals, polymers, composites and ceramics. At 5D biomaterial and medical device testing is carried out on many different materials, products and technologies. In particular, we routinely determine the efficacy of wound dressings in reference to their chemical and physical qualities and antimicrobial performance, the antimicrobial finishes on textile products and testing of other medical devices that help to support product claims and marketing literature.

To discuss your biomaterial and wound dressing testing needs please contact us at info@5Dhpg.com or call on +44 (0) 151 794 9279.